Trial · NCT01972841
This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder
NCT01972841, Phase 3, Completed, Astellas Pharma Europe B.V.; results first posted 2018-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder. Trials, record NCT01972841. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01972841
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder
- NCT number
- NCT01972841
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,527 participants, actual
- Lead sponsor
- Astellas Pharma Europe B.V.
- Conditions
- Urinary Bladder Overactive, Urinary Bladder Diseases\Urologic Diseases, Overactive Bladder, Urgency Incontinence
- Interventions
- Solifenacin succinate, Mirabegron, Placebo to match solifenacin succinate, Placebo to match mirabegron
- First posted
- 2013-10-31
- Last updated
- 2024-10-31
- Other registries' IDs
- eudract:2012-005735-91
- Results first posted
- 2018-06-12
- Limitations and caveats
- Due to lack of data integrity, one site's data was not included in the efficacy and safety analysis.
Source ClinicalTrials.gov
Registered outcomes70
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and EoT (up to 12 weeks) | An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period. |
| Primary | Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours | Baseline and EoT (up to 12 weeks) | A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period. |
| Secondary | Change From Baseline to EoT in Mean Volume Voided Per Micturition | Baseline and EoT (up to 12 weeks) | The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period. |
| Secondary | Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score | Baseline and EoT (up to 12 weeks) | The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement. |
| Secondary | Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS) | Baseline and EoT (up to 12 weeks) | The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement. |
| Secondary | Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT | Weeks 4, 8, 12 and EoT (up to 12 weeks) | The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period. |
| Secondary | Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes | Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) | |
| Secondary | Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and weeks 4, 8 and 12 | |
| Secondary | Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours | Baseline and weeks 4, 8 and 12 | |
| Secondary | Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition | Baseline and weeks 4, 8 and 12 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 registered outcomesOutcomes70
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and EoT (up to 12 weeks) | FAS comprised all RAS patients who took ≥ 1 dose of double-blind treatment after randomization, reported ≥ 1 micturition in the baseline diary and ≥ 1 micturition postbaseline, reported ≥ 1 incontinence episode in the baseline diary and excluded participants from one site. Last observation carried forward (LOCF) was used for EoT. | incontinence episodes | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours | Baseline and EoT (up to 12 weeks) | FAS. LOCF was used for EoT. | micturitions | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to EoT in Mean Volume Voided Per Micturition | Baseline and EoT (up to 12 weeks) | FAS. LOCF was used for EoT. | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score | Baseline and EoT (up to 12 weeks) | FAS. LOCF was used for EoT. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS) | Baseline and EoT (up to 12 weeks) | FAS. LOCF was used for EoT. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT | Weeks 4, 8, 12 and EoT (up to 12 weeks) | FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. | incontinence episodes | MEAN |
| SECONDARY | Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes | Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks) | FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. | incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and weeks 4, 8 and 12 | FAS participants with available data at each time point were included in the analysis. | incontinence episodes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours | Baseline and weeks 4, 8 and 12 | FAS participants with available data at each time point data were included in the analysis. | micturitions | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition | Baseline and weeks 4, 8 and 12 | FAS participants with available data at each time point were included in the analysis. | mL | LEAST_SQUARES_MEAN |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 outcomesResults by group2,628
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | Placebo | -1.34 | Standard Error 0.10 | incontinence episodes | |
| Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | Mirabegron 25 mg | -1.70 | Standard Error 0.10 | incontinence episodes | |
| Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | Mirabegron 50 mg | -1.76 | Standard Error 0.10 | incontinence episodes | |
| Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | Solifenacin 5 mg | -1.79 | Standard Error 0.10 | incontinence episodes | |
| Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | Solifenacin 5 mg + Mirabegron 25 mg | -2.04 | Standard Error 0.07 | incontinence episodes | |
| Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours | Solifenacin 5 mg + Mirabegron 50 mg | -1.98 | Standard Error 0.07 | incontinence episodes | |
| Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours | Placebo | -1.64 | Standard Error 0.12 | micturitions | |
| Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours | Mirabegron 25 mg | -2.00 | Standard Error 0.12 | micturitions | |
| Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours | Mirabegron 50 mg | -2.03 | Standard Error 0.12 | micturitions | |
| Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours | Solifenacin 5 mg | -2.20 | Standard Error 0.12 | micturitions |
1 to 10 of 2,628Source ClinicalTrials.gov
See all 2,628 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 447 | |
| Overall Study | STARTED | Mirabegron 25 mg | 441 | |
| Overall Study | STARTED | Mirabegron 50 mg | 437 | |
| Overall Study | STARTED | Solifenacin 5 mg | 434 | |
| Overall Study | STARTED | Solifenacin 5 mg + Mirabegron 25 mg | 885 | |
| Overall Study | STARTED | Solifenacin 5 mg + Mirabegron 50 mg | 883 | |
| Overall Study | COMPLETED | Placebo | 404 | |
| Overall Study | COMPLETED | Mirabegron 25 mg | 397 | |
| Overall Study | COMPLETED | Mirabegron 50 mg | 387 | |
| Overall Study | COMPLETED | Solifenacin 5 mg | 397 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events330
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry mouth | Gastrointestinal disorders | Placebo | 8 | 429 | |
| other | Dry mouth | Gastrointestinal disorders | Mirabegron 25 mg | 17 | 423 | |
| other | Dry mouth | Gastrointestinal disorders | Mirabegron 50 mg | 14 | 422 | |
| other | Dry mouth | Gastrointestinal disorders | Solifenacin 5 mg | 25 | 423 | |
| other | Dry mouth | Gastrointestinal disorders | Solifenacin 5 mg + Mirabegron 25 mg | 72 | 853 | |
| other | Dry mouth | Gastrointestinal disorders | Solifenacin 5 mg + Mirabegron 50 mg | 60 | 848 | |
| serious | Appendicitis | Infections and infestations | Placebo | 0 | 429 | |
| serious | Appendicitis | Infections and infestations | Mirabegron 25 mg | 0 | 423 | |
| serious | Appendicitis | Infections and infestations | Mirabegron 50 mg | 1 | 422 | |
| serious | Appendicitis | Infections and infestations | Solifenacin 5 mg | 0 | 423 |
1 to 10 of 330Source ClinicalTrials.gov
See all 330 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 429 |
| Total, all-cause mortality | Mirabegron 25 mg | 0 | 423 |
| Total, all-cause mortality | Mirabegron 50 mg | 0 | 422 |
| Total, all-cause mortality | Solifenacin 5 mg | 0 | 423 |
| Total, all-cause mortality | Solifenacin 5 mg + Mirabegron 25 mg | 0 | 853 |
| Total, all-cause mortality | Solifenacin 5 mg + Mirabegron 50 mg | 0 | 848 |
| Total, other adverse events | Placebo | 8 | 429 |
| Total, other adverse events | Mirabegron 25 mg | 17 | 423 |
| Total, other adverse events | Mirabegron 50 mg | 14 | 422 |
| Total, other adverse events | Solifenacin 5 mg | 25 | 423 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37160401 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01972841
GET https://conductscience.org/api/trials/v1/NCT01972841/registered?page=2